Moderator: Ian Crone, ArisGlobal

Panellists:

• Remco Munnik (Arcana Life Sciences)
• Peter Brandstetter (Accenture)
• Frits Stulp (Implement Consulting Group)

In this episode, the focus is on IDMP and its role in transitioning from document-based to data-driven regulatory affairs. Key points include the status of IDMP adoption within the EU, the readiness and challenges of current systems, and the potential of structured data to empower AI applications.

The conversation highlights how structured, high-quality product data can enhance regulatory processes, from signal detection to submission automation. Participants stress the importance of robust data foundations, referencing examples from other industries and emphasizing the transformative potential of data governance. The discussion concludes with actionable steps for companies to make meaningful progress, emphasizing the alignment of leadership, structure, tooling, and mindset in embracing data and AI for improved healthcare delivery.

00:42 Episode Overview: IDMP in Motion 01:04 Guest Introductions 01:35 Current State of EU IDMP Adoption 03:01 EMA's Role and Data Management 08:04 AI Applications in Regulatory Affairs 12:22 The Importance of Data Quality 13:07 Future of AI and IDMP in Regulatory Affairs 17:35 Challenges and Solutions for Implementation 23:39 Predictions for the Future 28:45 Actionable Steps for Companies 32:12 Conclusion and Final Thoughts